| 无菌隔离舱在药品无菌检查中应用的验证 |
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| 引用本文： | 王知坚,刘咏梅. 无菌隔离舱在药品无菌检查中应用的验证[J]. 中国药事, 2005, 19(2): 79-81 |
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| 作者姓名： | 王知坚 刘咏梅 |
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| 作者单位： | 浙江省药品检验所,杭州,310004 |
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| 摘 要： | 对无菌隔离舱在药品无菌检查中是否适用进行验证.验证实验采用运行确认和性能确认的方法.结果表明无菌隔离舱为药品无菌检查提供了一种可靠的实验环境.
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| 关 键 词： | 无菌隔离舱 无菌检查 验证 |
| 文章编号： | 1002-7777(2005)02-0079-03 |
Validation of Isolator System in Sterility Test of Drugs |
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| Wang Zhijian,Liu Yongmei. Validation of Isolator System in Sterility Test of Drugs[J]. Chinese Pharmaceutical Affairs, 2005, 19(2): 79-81 |
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| Authors: | Wang Zhijian Liu Yongmei |
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| Abstract: | The applicability of isolator system in sterility testin g for drugs was validated. The validation study was performed in phases of opera tion qualification and performance qualification. Isolator system was validated to be credible equipment in sterility testing for drugs. |
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| Keywords: | isolator system sterility testing validation |
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